Iso-Tex Diagnostics
Country not established
- Devices
- 3
What Iso-Tex Diagnostics makes
Iso-Tex Diagnostics produces radioimmunoassay (RIA) kits for laboratory testing, including APO B and APO A-I assays for human plasma, as well as a parathyroid hormone RIA system.
These products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II, and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Apo B Ria Kit Ref K851389
Regimes: 510(k) Registry: 510(k)Apo A-I Ria Kit-Human Plasma Apolip- Ref K840105
Regimes: 510(k) Registry: 510(k)Ria System, Parathyroid Hormone Ref K782081
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iso-Tex Diagnostics have in the registry?
The registry currently lists 3 devices for Iso-Tex Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iso-Tex Diagnostics's devices?
Among its 3 most recently registered devices, Iso-Tex Diagnostics has devices listed in FDA 510(k) (3 devices).
What risk classes do Iso-Tex Diagnostics's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Iso-Tex Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iso-Tex Diagnostics in the registry?
The most recently registered devices listed for Iso-Tex Diagnostics include APO B RIA KIT, APO A-I RIA KIT-HUMAN PLASMA APOLIP- and RIA SYSTEM, PARATHYROID HORMONE.